PACE-UP (Pedometer and consultation evaluation - UP) – a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45–75 years: study protocol for a randomised controlled trial

Trials

Derek G Cook²  Rebecca Dale²  Emma Howard²  Cheryl Furness²  Nana Anokye⁵  Elizabeth Limb²  Stephen DeWilde²  Judith Ibison²  Debbie Brewin³  Lee David³  Peter Whincup²  Julia Fox-Rushby⁵  Ulf Ekelund⁴  Michael Ussher²  Steve Iliffe¹  Sunil M Shah²  Christina R Victor⁷  Sally M Kerry⁶  Tess Harris² 

[1] Department of Population Health Sciences, University College, London NW3 2PF, UK;Population Health Research Centre, St George’s University of London, London SW17 ORE, UK;10 Minute CBT, Devonshire Business Centre, Letchworth Garden City, Herts SG61GJ, UK;Department of Sport Medicine, Norwegian School of Sport Sciences, PO Box 4014, 0806 Oslo, Norway;Health Economics Research Group, Brunel University, London UB83PH, UK;Pragmatic Clinical Trials Unit, Queen Mary’s University of London, London E12AT, UK;Gerontology and Health Services Research Unit, Brunel University, London UB8 3PH, UK

关键词: Walking intervention;    Primary care;    Practice nurse;    Postal;    Physical activity;    Pedometers;    Older people;    Middle-aged adults;    Cognitive behavioural;    Behaviour change techniques;    Accelerometers;   

Others  :  807842
DOI  :  10.1186/1745-6215-14-418

 received in 2013-09-09, accepted in 2013-11-20,  发布年份 2013

【 摘 要 】

Background

Most adults do not achieve the 150 minutes weekly of at least moderate intensity activity recommended for health. Adults’ most common physical activity (PA) is walking, light intensity if strolling, moderate if brisker. Pedometers can increase walking; however, most trials have been short-term, have combined pedometer and support effects, and have not reported PA intensity. This trial will investigate whether pedometers, with or without nurse support, can help less active 45–75 year olds to increase their PA over 12 months.

Methods/design

Design: Primary care-based 3-arm randomized controlled trial with 12-month follow-up and health economic and qualitative evaluations.

Participants: Less active 45–75 year olds (n = 993) will be recruited by post from six South West London general practices, maximum of two per household and households randomised into three groups. Step-count and time spent at different PA intensities will be assessed for 7 days at baseline, 3 and 12 months by accelerometer. Questionnaires and anthropometric assessments will be completed.

Intervention: The pedometer-alone group will be posted a pedometer (Yamax Digi-Walker SW-200), handbook and diary detailing a 12-week pedometer-based walking programme, using targets from their baseline assessment. The pedometer-plus-support group will additionally receive three practice nurse PA consultations. The handbook, diary and consultations include behaviour change techniques (e.g., self-monitoring, goal-setting, relapse prevention planning). The control group will receive usual care.

Outcomes: Changes in average daily step-count (primary outcome), time spent sedentary and in at least moderate intensity PA weekly at 12 months, measured by accelerometry. Other outcomes include change in body mass index, body fat, self-reported PA, quality of life, mood and adverse events. Cost-effectiveness will be assessed by the incremental cost of the intervention to the National Health Service and incremental cost per change in step-count and per quality adjusted life year. Qualitative evaluations will explore reasons for trial non-participation and the interventions’ acceptability.

Discussion

The PACE-UP trial will determine the effectiveness and cost-effectiveness of a pedometer-based walking intervention delivered by post or practice nurse to less active primary care patients aged 45–75 years old. Approaches to minimise bias and challenges anticipated in delivery will be discussed.

Trial registration

ISRCTN98538934

【 授权许可】

   
2013 Harris et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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